P3 Study Brodalumab in Treatment of Moderate to Severe Plaque Psoriasis (AMAGINE-2)

A Phase 3 Study to Evaluate the Efficacy and Safety of Induction and Maintenance Regimens of Brodalumab Compared With Placebo and Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-2

The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses

Study Overview

• Status: Terminated
• Conditions: Moderate to Severe Plaque Psoriasis
• Intervention / Treatment: Drug: 210 mg brodalumab; Drug: 140 mg brodalumab; Drug: ustekinumab; Drug: placebo

Detailed Description

.The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses compared with placebo in participants with moderate to severe plaque psoriasis. A second purpose of this study is to assess the safety and efficacy brodalumab at two different doses compared with ustekinumab in participants with moderate to severe plaque psoriasis. A third purpose of this study is to assess the safety and efficacy of 4 maintenance regimens of brodalumab.

• Study Type: Interventional
• Enrollment (Actual): 1831
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Australian Capital Territory
    • Phillip, Australian Capital Territory, Australia, 2606
      • Research Site
  • New South Wales
    • Kogarah, New South Wales, Australia, 2217
      • Research Site
  • Queensland
    • Benowa, Queensland, Australia, 4217
      • Research Site
    • Gold Coast, Queensland, Australia, 4217
      • Research Site
    • Woolloongabba, Queensland, Australia, 4102
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  • Victoria
    • Box Hill, Victoria, Australia, 3128
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    • Carlton, Victoria, Australia, 3053
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    • Parkville, Victoria, Australia, 3050
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• Austria
  • Graz, Austria, 8036
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  • Innsbruck, Austria, 6020
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  • Linz, Austria, 4020
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  • Wien, Austria, 1130
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  • Wien, Austria, 1090
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  • Wien, Austria, 1030
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• Canada
  • Alberta
    • Calgary, Alberta, Canada, T3A 2N1
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    • Edmonton, Alberta, Canada, T5K 1X3
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  • British Columbia
    • Surrey, British Columbia, Canada, V3R 6A7
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    • Vancouver, British Columbia, Canada, V5Z 3Y1
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  • Ontario
    • Ajax, Ontario, Canada, L1S 7K8
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    • Mississauga, Ontario, Canada, L5H 1G9
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    • Oakville, Ontario, Canada, L6J 7W5
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    • Ottawa, Ontario, Canada, K2G 6E2
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    • Peterborough, Ontario, Canada, K9J 1Z2
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    • Sudbury, Ontario, Canada, P3E 1H5
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    • Waterloo, Ontario, Canada, N2J 1C4
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    • Windsor, Ontario, Canada, N8W 1E6
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    • Windsor, Ontario, Canada, N8W 5L7
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  • Quebec
    • Montreal, Quebec, Canada, H3H 1V4
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• Czechia
  • Brno, Czechia, 656 91
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  • Jihlava, Czechia, 586 33
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  • Novy Jicin, Czechia, 741 01
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  • Praha 10, Czechia, 100 34
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  • Praha 5, Czechia, 150 06
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  • Praha 8, Czechia, 180 81
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  • Usti nad Labem, Czechia, 401 13
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• France
  • Amiens Cedex 1, France, 80504
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  • Besancon Cedex, France, 25030
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  • Brest Cedex, France, 29609
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  • Clermont-Ferrand, France, 63000
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  • Marseille cedex 05, France, 13385
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  • Montpellier cedex 5, France, 34295
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  • Paris Cedex 10, France, 75475
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  • Pessac Cedex, France, 33604
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  • Pierre-Bénite, France, 69495
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  • Rouen Cedex, France, 76031
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• Hungary
  • Budapest, Hungary, 1036
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  • Debrecen, Hungary, 4012
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  • Kecskemet, Hungary, 6000
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  • Miskolc, Hungary, 3529
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  • Nyiregyhaza, Hungary, 4400
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  • Veszprem, Hungary, 8200
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• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
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  • Breda, Netherlands, 4818 CK
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  • Nijmegen, Netherlands, 6525 GL
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  • Rotterdam, Netherlands, 3015 CA
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• Poland
  • Gdynia, Poland, 81-384
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  • Katowice, Poland, 40-040
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  • Lodz, Poland, 90-436
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  • Lodz, Poland, 90-265
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  • Lublin, Poland, 20-080
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  • Szczecin, Poland, 70-332
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  • Tarnow, Poland, 33-100
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  • Warszawa, Poland, 04-141
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  • Warszawa, Poland, 02-106
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  • Wroclaw, Poland, 50-088
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  • Wroclaw, Poland, 50-368
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  • Wroclaw, Poland, 51-318
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  • Wroclaw, Poland, 51-153
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  • Wroclaw, Poland, 53-658
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• Portugal
  • Coimbra, Portugal, 3000-075
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  • Lisboa, Portugal, 1649-035
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  • Porto, Portugal, 4200-319
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  • Porto, Portugal, 4050
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• Spain
  • Madrid, Spain, 28006
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  • AndalucÃ-a
    • Cordoba, AndalucÃ-a, Spain, 14004
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    • Córdoba, AndalucÃ-a, Spain, 14004
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    • Sevilla, AndalucÃ-a, Spain, 41009
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  • Aragón
    • Alcañiz, Aragón, Spain, 44600
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  • Baleares
    • Manacor, Baleares, Spain, 07500
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  • Cataluña
    • Badalona, Cataluña, Spain, 08916
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    • Barcelona, Cataluña, Spain, 08003
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    • Barcelona, Cataluña, Spain, 08036
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    • Barcelona, Cataluña, Spain, 08041
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    • Barcelona, Cataluña, Spain, 08025
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  • Comunidad Valenciana
    • Valencia, Comunidad Valenciana, Spain, 46014
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  • Galicia
    • A Coruña, Galicia, Spain, 15001
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  • Madrid
    • Alcorcon, Madrid, Spain, 28922
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• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
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  • Arizona
    • Tucson, Arizona, United States, 85710
      • Research Site
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
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  • California
    • Bakersfield, California, United States, 93309
      • Research Site
    • Beverly Hills, California, United States, 90211
      • Research Site
    • Irvine, California, United States, 92697
      • Research Site
    • Los Angeles, California, United States, 90045
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    • Los Angeles, California, United States, 90027
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    • Sacramento, California, United States, 95816
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    • San Diego, California, United States, 92123
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    • San Diego, California, United States, 92103
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    • Vista, California, United States, 92083
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  • Colorado
    • Denver, Colorado, United States, 80210
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    • Denver, Colorado, United States, 80239
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    • Denver, Colorado, United States, 80209
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  • Connecticut
    • New Haven, Connecticut, United States, 06511
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  • Florida
    • Aventura, Florida, United States, 33180
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    • Jacksonville, Florida, United States, 32216
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    • Miami, Florida, United States, 33136
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    • Pembroke Pines, Florida, United States, 33028
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    • Tampa, Florida, United States, 33612
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  • Georgia
    • Atlanta, Georgia, United States, 30342
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    • Newnan, Georgia, United States, 30263
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    • Snellville, Georgia, United States, 30078
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  • Illinois
    • Chicago, Illinois, United States, 60611
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    • Chicago, Illinois, United States, 60654
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    • Skokie, Illinois, United States, 60077
      • Research Site
  • Indiana
    • Carmel, Indiana, United States, 46032
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    • Plainfield, Indiana, United States, 46168
      • Research Site
    • South Bend, Indiana, United States, 46617
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  • Kentucky
    • Louisville, Kentucky, United States, 40202
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  • Louisiana
    • Lake Charles, Louisiana, United States, 70601
      • Research Site
    • Lake Charles, Louisiana, United States, 70605
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    • New Orleans, Louisiana, United States, 70112
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  • Maryland
    • Rockville, Maryland, United States, 20850
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    • Silver Spring, Maryland, United States, 20902
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  • Massachusetts
    • Boston, Massachusetts, United States, 02115
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    • Boston, Massachusetts, United States, 02114
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    • North Andover, Massachusetts, United States, 01845
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  • Michigan
    • Ann Arbor, Michigan, United States, 48109
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  • Minnesota
    • Fridley, Minnesota, United States, 55432
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  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Research Site
  • Nevada
    • Henderson, Nevada, United States, 89074
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  • New York
    • Brooklyn, New York, United States, 11209
      • Research Site
    • New York, New York, United States, 10029
      • Research Site
    • Rochester, New York, United States, 14625
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  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • Research Site
    • Durham, North Carolina, United States, 27710
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    • Raleigh, North Carolina, United States, 27612
      • Research Site
    • Winston-Salem, North Carolina, United States, 27103
      • Research Site
  • Ohio
    • Beachwood, Ohio, United States, 44122
      • Research Site
    • Columbus, Ohio, United States, 43212
      • Research Site
    • Gahanna, Ohio, United States, 43230
      • Research Site
    • South Euclid, Ohio, United States, 44118
      • Research Site
  • Oregon
    • Portland, Oregon, United States, 97239
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  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Research Site
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Research Site
    • Mount Pleasant, South Carolina, United States, 29464
      • Research Site
  • Texas
    • Austin, Texas, United States, 78759
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    • Dallas, Texas, United States, 75246
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    • Houston, Texas, United States, 77065
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    • San Antonio, Texas, United States, 78229
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    • San Antonio, Texas, United States, 78249
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  • Utah
    • West Jordan, Utah, United States, 84088
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  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Research Site
    • Roanoke, Virginia, United States, 24016
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  • Washington
    • Seattle, Washington, United States, 98101
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject has had stable moderate to severe plaque psoriasis for at least 6 months
• Subject has involved body surface area (BSA) ≥ 10%, PASI ≥ 12, and sPGA ≥ 3 at screening and at baseline

Exclusion Criteria:

• Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions at (eg, eczema) that would interfere with study evaluations
• Subject has known history of Crohn's disease
• Subject has any other significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol
• Subject has not stopped using certain psoriasis therapies as defined in the study protocol
• Subject has previously used ustekinumab or any anti-IL-17 biologic therapy
• Subject is pregnant or breastfeeding, or planning to become pregnant while enrolled in the study
• Female subject is unwilling to use highly effective methods of birth control unless 2 years post-menopausal or surgically sterile

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 210 mg brodalumab; Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.	Drug: 210 mg brodalumab; 210 mg brodalumab administered SC
Experimental: 140 mg brodalumab; Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.	Drug: 140 mg brodalumab; 140 mg brodalumab administered SC
Active Comparator: ustekinumab; Administered by subcutaneous (SC) injection per the labeled dosing regimen.	Drug: ustekinumab; 45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen.
Placebo Comparator: Placebo; Administered by subcutaneous (SC) injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.	Drug: 210 mg brodalumab; 210 mg brodalumab administered SC; Drug: placebo; Placebo administered SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12	Measures the physician's impression of the disease at a single point, and a dynamic form in which the physician assesses the global improvement from baseline. Success is defined by a score of 0 or 1 (clear to almost clear).	12 weeks
Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12	to evaluate the efficacy of Brodalumab (210mg every 2 weeks, and 140mg every 2 weeks) in subjects with moderate to severe plaque psoriasis, as measured by the proportion of subjects achieving 75% improvement in Psoriasis Area and Severity Index, PASI75 at week 12.	12 weeks
Percentage of Participants With Psoriasis Area Severity Index (PASI) 100 at Week 12	to evaluate the efficacy of Brodalumab (210mg Q2W) in clearing psoriasis as measured by the proportion of subjects achieving PASI 100 at week 12.	12 Weeks

Collaborators and Investigators

• Sponsor: Bausch Health Americas, Inc.

Publications and helpful links

General Publications

• Gottlieb A, Lebwohl M, Liu C, Israel RJ, Jacobson A. Malignancy Rates in Brodalumab Clinical Studies for Psoriasis. Am J Clin Dermatol. 2020 Jun;21(3):421-430. doi: 10.1007/s40257-020-00512-4.
• Kokolakis G, Vadstrup K, Hansen JB, Carrascosa JM. Increased Skin Clearance and Quality of Life Improvement with Brodalumab Compared with Ustekinumab in Psoriasis Patients with Aggravating Lifestyle Factors. Dermatol Ther (Heidelb). 2021 Dec;11(6):2027-2042. doi: 10.1007/s13555-021-00618-5. Epub 2021 Oct 2.
• McMichael A, Desai SR, Qureshi A, Rastogi S, Alexis AF. Efficacy and Safety of Brodalumab in Patients with Moderate-to-Severe Plaque Psoriasis and Skin of Color: Results from the Pooled AMAGINE-2/-3 Randomized Trials. Am J Clin Dermatol. 2019 Apr;20(2):267-276. doi: 10.1007/s40257-018-0408-z.
• Langley RG, Armstrong AW, Lebwohl MG, Blauvelt A, Hsu S, Tyring S, Rastogi S, Pillai R, Israel R. Efficacy and safety of brodalumab in patients with psoriasis who had inadequate responses to ustekinumab: subgroup analysis of two randomized phase III trials. Br J Dermatol. 2019 Feb;180(2):306-314. doi: 10.1111/bjd.17318. Epub 2018 Dec 27.
• Lebwohl M, Strober B, Menter A, Gordon K, Weglowska J, Puig L, Papp K, Spelman L, Toth D, Kerdel F, Armstrong AW, Stingl G, Kimball AB, Bachelez H, Wu JJ, Crowley J, Langley RG, Blicharski T, Paul C, Lacour JP, Tyring S, Kircik L, Chimenti S, Callis Duffin K, Bagel J, Koo J, Aras G, Li J, Song W, Milmont CE, Shi Y, Erondu N, Klekotka P, Kotzin B, Nirula A. Phase 3 Studies Comparing Brodalumab with Ustekinumab in Psoriasis. N Engl J Med. 2015 Oct;373(14):1318-28. doi: 10.1056/NEJMoa1503824.

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: September 12, 2012
• First Submitted That Met QC Criteria: October 15, 2012
• First Posted (Estimate): October 17, 2012

Study Record Updates

• Last Update Posted (Actual): January 6, 2020
• Last Update Submitted That Met QC Criteria: January 3, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: psoriasis, brodalumab, AMG 827
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Immunologic Factors; Dermatologic Agents; Antibodies, Monoclonal; Brodalumab; Ustekinumab
• Other Study ID Numbers: 20120103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES